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Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery (PR-PROS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01766492
First received: January 9, 2013
Last updated: June 10, 2014
Last verified: February 2014

January 9, 2013
June 10, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
  • fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding fatigue
  • urinary symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery
  • bowel symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery
  • sexual function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery
Same as current
Complete list of historical versions of study NCT01766492 on ClinicalTrials.gov Archive Site
  • cancer control [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    clinical evidence of localized and distal cancer controls
  • toxicity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire
Same as current
Not Provided
Not Provided
 
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)

Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.

Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):

The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.

Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.

Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.

Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Men (> 18 y/o) with clinically localized prostate cancer,

Clinically Localized Prostate Cancer
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Other Name: CyberKnife radiosurgery
male adults (age > 18 y/o) with prostate cancer
Men received radiosurgery for clinically localized prostate cancer
Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; on behalf of the RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 May 4; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of prostate
  • Signed study-specific consent
  • Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Prior radical prostate surgery
  • Medical or psychiatric illness that would interfere with treatment or follow up
  • Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
Male
18 Years and older
No
Contact: Robyn A Cyr 202-444-3068 Robyn.A.Cyr@gunet.georgetown.edu
Contact: Sean P Collins, MD, PhD 202-444-3292 spc9@gunet.georgetown.edu
United States
 
NCT01766492
2012-1175
No
Georgetown University
Georgetown University
Not Provided
Not Provided
Georgetown University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP